Prepared for the WHO Department of Public Health, Innovation and Intellectual
Property by Warren A. Kaplan (Center for Global Health & Development, Boston University,
United States). This report forms part of the project entitled: Improving access to medicines in
developing countries through technology transfer related to medical products and local
production. It is implemented by the Department of Public Health Innovation and Intellectual
Property of the World Health Organization (WHO/PHI) in partnership with the United Nations
Conference on Trade and Development (UNCTAD) and the International Centre for Trade and
Sustainable Development (ICTSD) with funding from the European Union (EU). The overall
objective of the project is to increase access – especially for the poor in developing and least
developed countries – to medicines, vaccines and diagnostics.

For the pharmaceutical sector, policy-makers around the world continually struggle to balance health policy objectives (e.g., access to affordable and essential medicines) with those of industrial policy in the pharmaceutical sector (e.g., promoting innovation and local research and development (R&D) activity). Tensions particularly arise over pricing and reimbursement. Limited health care budgets – and competing demands for scarce resources – force governments to set limits on which medicines to provide or subsidize, for whom and at what price. What ministries of health and/or health plans view as necessary to maintain equitable access to medicines, industry may view as detrimental to R&D and innovation.

This report explores the interface between industrial and health policies.
Based on a literature review in the field, the report summarizes previous theoretical and empirical work on local production (LP) of biomedical products, and its potential impact on access to medicines. By ‘products’ we mean medicines and devices, including diagnostics. The report:

Assesses to what extent the linkages between LP and access were explored
in previous studies;

Critically analyzes whether the methods employed in the literature were
sufficient to suggest a robust relationship between LP and access;